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Effectiveness of Mindfulness-Integrated Cognitive Behaviour Therapy and Schema Therapy on the Emotional States and the Quality of life of People with Multiple Sclerosis

Protocol summary

Study aim
Effectiveness of Mindfulness-Integrated Cognitive Behavior Therapy and Schema Therapy on the Emotional States(Depression, anxiety, stress) and the Quality of life of People with Multiple Sclerosis.
Design
The sample consisted of 45 patients with MS. At first, the sample of this study was considered for each group of 20. MiCBT intervention was applied based on the protocol developed by Cayon (2011) at nine sessions(2 hours) in , as well as ST was applied based on the protocol developed by Jeffrey Young (2003) at 12 sessions(2hours), and no intervention was presented in the control group. These psychological interventions were considered as independent variables and emotional states, and quality of life of patients with ms as dependent variables.
Settings and conduct
at first, we referred to MS society of Kerman. MS patients were invited to participate in this intervention by calling and informing them in person. Then, among those who enrolled, some that had criteria to entry into the research were informed to be present at intervention. They were randomly assigned into two experimental groups: micbt, ST and one control group.
Participants/Inclusion and exclusion criteria
being patient based on Neurologist diagnosis no addiction Non-use of psychiatric medication simultaneously with the intervention Not using other psychological treatments simultaneously
Intervention groups
This study was applied on two experimental groups and one control group, each group was include of 20 people with multiple sclerosis. Psychological intervention was applied on two levels: level 1 MiCBT and Level 2, ST, and the control group did not receive any therapeutic intervention.
Main outcome variables
improving depression, anxiety and stress of MS patients Improving the quality of life of MS patients Evaluating the effectiveness of MICBT and ST therapy on emotional states and quality of life in MS patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180922041082N2
Registration date: 2019-01-28, 1397/11/08
Registration timing: retrospective

Last update: 2019-01-28, 1397/11/08
Update count: 0
Registration date
2019-01-28, 1397/11/08
Registrant information
Name
Masoud Fazilat-Pour
Name of organization / entity
Shiraz University
Country
Iran (Islamic Republic of)
Phone
+98 34 3613 4670
Email address
fazilatm@uk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-04-09, 1396/01/20
Actual recruitment start date
2017-03-05, 1395/12/15
Actual recruitment end date
2017-04-09, 1396/01/20
Trial completion date
2017-07-21, 1396/04/30
Scientific title
Effectiveness of Mindfulness-Integrated Cognitive Behaviour Therapy and Schema Therapy on the Emotional States and the Quality of life of People with Multiple Sclerosis
Public title
Effectiveness of Mindfulness-Integrated Cognitive Behaviour Therapy and Schema Therapy on the Emotional States and the Quality of life of People with Multiple Sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being patient based on Neurologist diagnosis no addiction Non-use of psychiatric medication simultaneously with the intervention Not using other psychological treatments simultaneously with the intervention
Exclusion criteria:
Failure to perform treatment exercises Abandoned Over-Allowed
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 55
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
At first, referred to the Kerman province, ms patients were invited to attend in intervention. Then, among those who enrolled, they were randomly selected and drawn into two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The present research is a semi-experimental design with pre-test and post-test with the control group.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee, Department of Psychology, Shahid-Bahonar University, Kerman
Street address
Literature and Human Science department, Shahid Bahonar university, Research Square, Imam Khomeini highway
City
Kerman
Province
Kerman
Postal code
7616914111
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
E.A.95.12.22-02

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

2

Description of health condition studied
Emotional states (depression, anxiety, stress)
ICD-10 code
R45
ICD-10 code description
Symptoms and signs involving emotional state

Primary outcomes

1

Description
Emotional states that include depression, anxiety and stress are measured by the scale of depression, anxiety and stress (DASS-21). And they can be mild, moderate, and severe.
Timepoint
The emotional states were measured once before the intervention in the first session (pre-test) and one time at the end of the intervention in the final session (post-test).
Method of measurement
The DASS-21 scale was used to measure emotional states, which has 21 questions with Likert scale and has a good validity and reliability.

2

Description
Quality of life of MS patients measured by MS-QOL scale. And the 3 overall scales includes physical health, health and quality of life.
Timepoint
The Quality of life was measured once before the intervention in the first session (pre-test) and one time at the end of the intervention in the final session (post-test).
Method of measurement
The quality of life of MS patients was measured by MS-QOL scale, which is specific to assessing the quality of life of these patients. This scale has 54 questions for assessing 14 areas related to physical health and mental health, and its validity and reliability are confirmed by studies.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Mindfulness integrated cognitive behavioral therapy (MICBT) in 8 sessions based on Cayon protocol.
Category
Behavior

2

Description
Intervention group: Group Schema Consulting Group in 12 sessions based on the Yang Protocol (2003)
Category
Behavior

3

Description
Control group: no treatment has been applied
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Samen Al-Hojaj charity
Full name of responsible person
Hossein Nakhai Abdul Abadi
Street address
the end of Shahid Rajaee avenue
City
Kerman
Province
Kerman
Postal code
7619875994
Phone
+98 34 3271 2001
Email
www.kmu_nrc@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hossein Ali Ebrahimi
Street address
Kosar Blv
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
kmu_nrc@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shaid Bahonar University
Full name of responsible person
Masoud Fazilat pour
Position
Associat professor
Latest degree
Ph.D.
Other areas of specialty/work
psychology
Street address
Imam Khomeini Blv
City
کرمان
Province
Kerman
Postal code
7616914111
Phone
+98 34 3132 2393
Email
fazilatm@uk.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Bahonar university
Full name of responsible person
Masoud Fazilatpour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
psychology
Street address
Imam Khomeini Highway, Pajoohesh Sq., Shahid Bahonar University, Kerman
City
Kerman
Province
Kerman
Postal code
7616913439
Phone
+98 34332571415
Email
Fazilatm@uk.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Bahonar university
Full name of responsible person
Masoud Fazilatpour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
psychology
Street address
Imam Khomeini Highway, Pajoohesh Sq., Shahid Bahonar University, Kerman
City
Kerman
Province
Kerman
Postal code
7616913439
Phone
+98 34332571415
Email
Fazilatm@ul.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
the data are collected anonymously
When the data will become available and for how long
in case of request the data are available anonymous
To whom data/document is available
the further researchers with credible studies from reputable constitutions
Under which criteria data/document could be used
researchers with credible studies from reputable constitutions
From where data/document is obtainable
after the article got published
What processes are involved for a request to access data/document
contact with the corresponding author
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